MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12; QEW

Model Number	LITNG12XTORQ100-A
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, an investigation cannot be performed.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the pulmonary artery using a lightning aspiration tubing (lightning), an indigo system cat12 aspiration catheter (cat12), penumbra engine (engine), and penumbra engine canister (canister).During the procedure, after approximately five minutes of using the lightning, the indicator light started flashing red.The physician unplugged and plugged the lightning unit back into the engine to troubleshoot; however, the indicator light turned from green to flashing red when the switch was turned into the on position.It was also reported that the canister was completely seated on the engine and the lid was tightly sealed.Therefore, the lightning unit was removed.The procedure was completed using a new lightning with the same cat12, engine, and canister.There was no adverse effect to the patient.

• Brand Name: INDIGO SYSTEM LIGHTNING 12
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11953377
• Report Number: 3005168196-2021-01269
• Device Sequence Number: 17248408
• Product Code: QEW
• UDI-Device Identifier: 00815948022560
• UDI-Public: 00815948022560
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K200771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2021
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/30/2023
• Device Model Number: LITNG12XTORQ100-A
• Device Catalogue Number: LITNG12XTORQ100
• Device Lot Number: F103017
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005